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DEEP OSCILLATION Evident
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 02034-GModel DEEP OSCILLATION
Identity
- Trade Name
- DEEP OSCILLATION Evident EUDAMEDDEEP OSCILLATION® Evident FDA UDI
- Generic Name
- Hand-held electric massager FDA UDI
- Model / Reference
- DEEP OSCILLATION EUDAMED02034-G EUDAMEDDOE2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04099649000041 EUDAMEDFDA UDI
- Basic UDI-DI
- 4099649DEEPOSZILLATION2F EUDAMED
- Direct Marketing DI
- 04099649000041 EUDAMED
- FDA Product Code
- ISA FDA UDI
- EMDN Code
- Z12062799 FUNCTIONAL ELECTRICAL STIMULATION SYSTEMS - OTHER EUDAMED
- GMDN Term
- Hand-held electric massager FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 890.5660 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
DEEP OSCILLATION Evident by Physiomed Elektromedizin Ag — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4099649DEEPOSZILLATION2F | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Physiomed Elektromedizin Ag
- EUDAMED SRN
- DE-MF-000009637
Sources (2)
- EUDAMED a3b2dc58-273c-412b-94f1-36cd87bd4d15 61 fields · synced Jul 13, 2026
- FDA UDI 2f18d5a9-731f-4c68-8edf-a9ca5fb9b378 32 fields · synced May 30, 2026